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https://www.readbyqxmd.com/read/28316019/population-pharmacokinetic-analysis-of-rebamipide-in-healthy-korean-subjects-with-the-characterization-of-atypical-complex-absorption-kinetics
#1
Lien Ngo, Hee-Doo Yoo, Phuong Tran, Hea-Young Cho, Yong-Bok Lee
In this study, the population pharmacokinetic (PK) analysis of rebamipide (Reba) in healthy male Korean subjects was analyzed using the nonlinear mixed effects modeling method. The possible effects of physiological covariates and the multidrug resistance (MDR1) gene 3435C>T polymorphism on PK parameters were also investigated. Data were collected from a bioequivalence study, in which 26 subjects who participated in the study were administered a single oral dose of 100 mg Reba; only data from the reference formulation were used...
March 18, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28314990/an-apparent-clinical-pharmacokinetic-drug-drug-interaction-between-bevacizumab-and-the-anti-placental-growth-factor-monoclonal-antibody-ro5323441-via-a-target-trapping-mechanism
#2
Ka Wang, Franziska Schaedeli Stark, Tilman Schlothauer, Angelika Lahr, Valerie Cosson, Jianguo Zhi, Kai Habben, Jean Tessier, Eginhard Schick, Roland F Staack, Oliver Krieter
PURPOSE: RO5323441 is a humanized anti-placental growth factor (PlGF) monoclonal antibody that has shown preclinical activity in several cancer models. The objective of this analysis is to examine the pharmacokinetic (PK) results from four Phase I studies that have been conducted with RO5323441 (n = 61) and to report an apparent drug-drug interaction observed when RO5323441 was administered in combination with bevacizumab. METHODS: The four Phase I studies were a multiple-ascending dose study in 23 patients with solid tumors (Study 1), an open-label study in seven patients with colorectal/ovarian cancer (Study 2), a sorafenib combination study in nine patients with hepatocellular carcinoma (Study 3), and a bevacizumab combination study in 22 patients with recurrent glioblastoma (Study 4)...
March 17, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28297816/-population-pharmacokinetics-of-vancomycin-from-severe-in-patients-with-lower-respiratory-tract-infection
#3
W Yang, B He, C H Deng
Objective: To develop a population pharmacokinetic (PPK) model of vancomycin in Chinese inpatients with severe lower respiratory tract infection. Methods: We gathered serum concentrations of vancomycin from inpatients who received vancomycin during Nov 2011 to Nov 2012.Vancomycin serum concentrations was measured by high performance liquid chromatography. Vancomycin PPK analysis was performed using nonlinear mixed effects model (NONMEM) program. Results: We gathered the data of 70 inpatients with lower respiratory tract infection at respiratory ward or respiratory intensive care unit(RICU) between Nov 2011 to Nov 2012 [58 males, 12 females; 78(23-91) years old; the mean of APACHⅡ score was 16...
March 12, 2017: Chinese Journal of Tuberculosis and Respiratory Diseases
https://www.readbyqxmd.com/read/28294391/a-population-pharmacokinetic-meta-analysis-of-custirsen-an-antisense-oligonucleotide-in-oncology-patients-and-healthy-subjects
#4
Alena Y Edwards, Anna Elgart, Colm Farrell, Ofra Barnett-Griness, Laura Rabinovich-Guilatt, Ofer Spiegelstein
AIMS: Custirsen (OGX-011/TV-1011), a second-generation antisense oligonucleotide that reduces clusterin production, is under investigation with chemotherapy in prostate and lung cancer. This meta-analysis evaluated the population pharmacokinetics (PK) of custirsen in cancer patients and healthy subjects. METHODS: The population PK analysis used custirsen plasma concentrations from five phase 1 studies, one phase 1/2 study, and one phase 3 study in two stages. Cancer patients received multiple doses of custirsen (40-640 mg intravenously over 120 minutes) with chemotherapy; healthy subjects received single or multiple doses (320-640 mg)...
March 11, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28294376/influence-of-the-pharmacokinetic-profile-on-the-plasma-glucose-lowering-effect-of-ppar%C3%AE-agonist-pioglitazone-in-wistar-fatty-rats
#5
Akihiko Goto, Yoshihiko Tagawa, Yoshiaki Kimura, Akifumi Kogame, Yuu Moriya, Nobuyuki Amano
Although the mechanism of action for peroxisome proliferator-activated receptor gamma (PPARγ) agonists has been extensively explored, the impact of the pharmacokinetic (PK) profile on the pharmacodynamic (PD) effects of PPARγ agonists has not been elucidated in detail. We evaluated the importance of the PK profile of PPARγ agonist for its PD effect based on population PK/PD analysis. Pioglitazone hydrochloride, the PPARγ agonist, was administered orally to Wistar fatty rats once a day (qd) or once every other day (q2d) as double the amount for the qd treatment...
March 11, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28289034/the-impact-of-mucositis-on-absorption-and-systemic-drug-exposure-of-isavuconazole
#6
Laura L Kovanda, Francisco M Marty, Johan Maertens, Amit V Desai, Christopher Lademacher, Marc Engelhardt, Qiaoyang Lu, William W Hope
Isavuconazonium sulfate is the water-soluble prodrug of isavuconazole. Population analyses have demonstrated relatively predictable pharmacokinetic (PK) behavior in diverse patient populations. We evaluated the impact of mucositis on the oral isavuconazole exposure using population PK modeling. METHODS: We evaluated patients treated in two phase 3 trials of isavuconazole, SECURE for treatment of invasive aspergillosis (IA) and other filamentous fungi and VITAL for patients with mucormycosis, invasive fungal disease (IFD) caused by other rare fungi, or IA and renal impairment...
March 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28289033/population-pharmacokinetics-of-pyrazinamide-in-patients-with-tuberculosis
#7
Abdullah Alsultan, Rada Savic, Kelly E Dooley, Marc Weiner, William Whitworth, William R Mac Kenzie, Charles A Peloquin
The current treatment used for tuberculosis (TB) is lengthy and needs to be shortened and improved. Pyrazinamide (PZA) has potent sterilizing activity and has the potential to shorten TB treatment duration, if optimized. The goals of this study were (a) to develop a population pharmacokinetic (PK) model for PZA among patients enrolled in PK sub-studies of Tuberculosis Trial Consortium (TBTC) trials 27 and 28, and (b) to determine covariates that affect PZA PK. We also (c) performed simulations and target attainment analysis using the proposed targets of Cmax >35 mcg/ml or AUC >363 mcg*hr/ml to see if higher weight-based dosing could improve PZA efficacy...
March 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28289024/evaluation-of-a-bayesian-approach-to-estimate-vancomycin-exposure-in-obese-patients-with-limited-pharmacokinetic-sampling-a-pilot-study
#8
Joseph J Carreno, Ben Lomaestro, John Tietjan, Thomas P Lodise
This study evaluated the predictive performance of a Bayesian PK estimation method (ADAPT V) to estimate the 24-hour vancomycin area under the curve estimation (AUC) with limited PK sampling in adult obese patients receiving vancomycin for suspected or confirmed Gram-positive infections. This was an IRB-approved prospective evaluation of 12 patients. Patients had a median (95% CI) age of 61 years (39 - 71), creatinine clearance of 86 mL/min (75 - 120), and body mass index of 45 kg/m(2) (40 - 52). For each patient, five PK concentrations were measured and 4 different vancomycin population PK models were used as Bayesian priors to estimate the estimate vancomycin AUC (AUCFULL)...
March 13, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28281196/pharmacokinetics-of-the-inhaled-selective-glucocorticoid-receptor-modulator-azd5423-following-inhalation-using-different-devices
#9
Johanna Melin, Susanne Prothon, Charlotte Kloft, Adriaan Cleton, Carl Amilon, Carin Jorup, Per Bäckman, Bo Olsson, Ulrika Wählby Hamrén
AZD5423 is a non-steroidal glucocorticoid receptor modulator, with low aqueous solubility, developed for treatment of asthma and COPD. In this work, we aim to evaluate and compare the absorption pharmacokinetics (PK) of AZD5423 after inhalation via four devices, (Spira®, I-neb®, Turbuhaler® and a new dry powder inhaler (new DPI)) with two formulations using differently sized primary particles, and to compare the pulmonary bioavailability with the predicted lung deposited dose. Plasma concentration-time data after intravenous, oral and inhaled administration via four devices were available from two clinical studies in healthy and asthmatic subjects...
March 9, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28279893/population-pharmacokinetics-and-dose-response-relationship-of-levetiracetam-in-adult-patients-with-epilepsy
#10
Su-Jin Rhee, Jung-Won Shin, SeungHwan Lee, Jangsup Moon, Tae-Joon Kim, Ki-Young Jung, Kyung-Il Park, Soon-Tae Lee, Keun-Hwa Jung, Kyung-Sang Yu, In-Jin Jang, Kon Chu, Sang Kun Lee
Levetiracetam (LEV) is commonly used as a mono- or adjunctive therapy for treating patients with partial and generalized epilepsy. This study aimed to develop a population pharmacokinetic (PK) model of LEV, based on sparse data, and to explore LEV efficacy relative to its PK properties in patients with epilepsy. We included 483 LEV concentrations from 425 patients with epilepsy that received multiple oral LEV doses. We performed a population PK analysis, implemented in NONMEM (version 7.2). In addition, we explored the relationships between seizure control and PK variables (i...
February 27, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28278315/biochemical-effects-of-exercise-on-a-fasciocutaneous-flap-in-a-rat-model
#11
Edita Aksamitiene, Adam L Baker, Sudeep Roy, Salini Hota, Li-Hui Zhang, Julianna Rodin, Kealan Hobelmann, Jan B Hoek, Edmund A Pribitkin
Importance: An overwhelming amount of data suggest that cardiovascular exercise has a positive effect on the mind and body, although the precise mechanism is not always clear. Objective: To assess the clinical and biochemical effects of voluntary cardiovascular exercise on pedicled flaps in a rodent model. Design, Setting, and Participants: Eighteen adult Sprague-Dawley male rats were randomized into a resting animal group (RAG) (n=9) and an exercise animal group (EAG) (n=9) for 14 days (July 23, 2013, through July 30, 2013)...
March 9, 2017: JAMA Facial Plastic Surgery
https://www.readbyqxmd.com/read/28277032/novel-avenues-for-treating-diabetic-nephropathy-new-investigational-drugs
#12
Viviana Lacava, Vincenzo Pellicanò, Carmen Ferrajolo, Valeria Cernaro, Luca Visconti, Giovanni Conti, Michele Buemi, Domenico Santoro
At present, treatment of diabetic kidney disease (DKD) is still mainly based on drugs acting on glycemic and blood pressure control, as there is no validated therapy able to halt the progression of renal failure. Because of the high incidence of DKD, due to the increase of diabetes mellitus in general population, new therapeutic strategies are needed. Areas covered: We analysed ongoing and already completed clinical trials, from clinicaltrials.gov and PubMed, dealing with new therapies for DKD. Expert opinion: Among the drugs currently being explored, the most promising molecules are those that interfere with glucose-dependent pathways, in particular polyol, protein kinase, hexosamine and AGEs metabolic pathways, and impaired renal vascular regulation...
February 17, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28274793/pkk-deficiency-in-b-cells-prevents-lupus-development-in-sle-lupus-mice
#13
D Oleksyn, J Zhao, A Vosoughi, J C Zhao, R Misra, A P Pentland, D Ryan, J Anolik, C Ritchlin, J Looney, A P Anandarajah, G Schwartz, L M Calvi, M Georger, C Mohan, I Sanz, L Chen
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of autoantibodies that can result in damage to multiple organs. It is well documented that B cells play a critical role in the development of the disease. We previously showed that protein kinase C associated kinase (PKK) is required for B1 cell development as well as for the survival of recirculating mature B cells and B-lymphoma cells. Here, we investigated the role of PKK in lupus development in a lupus mouse model...
March 6, 2017: Immunology Letters
https://www.readbyqxmd.com/read/28273356/population-pharmacokinetic-modeling-of-secukinumab-in-patients-with-moderate-to-severe-psoriasis
#14
Gerard Bruin, Christian Loesche, Judit Nyirady, Oliver Sander
Secukinumab is a human monoclonal antibody with demonstrated efficacy for moderate to severe psoriasis; it binds to and neutralizes interleukin (IL)-17A. The pharmacokinetic (PK) parameters of secukinumab were best described by a 2-compartment model. Only weight was included in the final model, as other covariates did not affect clinical relevance. The estimated serum clearance of secukinumab was 0.19 L/day, with interindividual variability (IIV) of 32% coefficient of variation (CV), and low total volume of distribution (central compartment volume, 3...
March 8, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28266713/personalised-dosing-of-medicines-for-children
#15
REVIEW
Basma Al-Metwali, Hussain Mulla
OBJECTIVES: Doses for most drugs are determined from population-level information, resulting in a standard ?one-size-fits-all' dose range for all individuals. This review explores how doses can be personalised through the use of the individuals' pharmacokinetic (PK)-pharmacodynamic (PD) profile, its particular application in children, and therapy areas where such approaches have made inroads. KEY FINDINGS: The Bayesian forecasting approach, based on population PK/PD models that account for variability in exposure and response, is a potent method for personalising drug therapy...
March 7, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28255999/development-of-a-physiologically-based-pharmacokinetic-model-to-predict-the-effects-of-flavin-containing-monooxygenase-3-fmo3-polymorphisms-on-itopride-exposure
#16
Wangda Zhou, Helen Humphries, Sibylle Neuhoff, Iain Gardner, Eric Masson, Nidal Al-Huniti, Diansong Zhou
Itopride, a substrate of FMO3, has been used for the symptomatic treatment of various gastrointestinal disorders. Physiologically based pharmacokinetic (PBPK) modeling was applied to evaluate the impact of FMO3 polymorphism on itopride pharmacokinetics (PK). The Asian populations within the Simcyp simulator were updated to incorporate information on frequency, activity and abundance of FMO3 enzyme with different phenotypes. A meta-analysis of relative enzyme activities suggested that FMO3 activity in subjects with homozygous Glu158Lys and Glu308Gly mutations (Lys158 and Gly308) in both alleles is ~47% lower than those carrying two wild-type FMO3 alleles...
March 3, 2017: Biopharmaceutics & Drug Disposition
https://www.readbyqxmd.com/read/28255849/population-pharmacokinetics-of-cladribine-in-patients-with-multiple-sclerosis
#17
Radojka M Savic, Ana M Novakovic, Marianne Ekblom, Alain Munafo, Mats O Karlsson
PURPOSE: The aims of this study were to characterize the concentration-time course of cladribine (CdA) and its main metabolite 2-chloroadenine (CAde), estimate interindividual variability in pharmacokinetics (PK), and identify covariates explaining variability in the PK of CdA. METHODS: This population PK analysis was based on the combined dataset from four clinical studies in patients with multiple sclerosis (MS): three phase I studies, including one food and one drug-drug interaction study, and one phase III clinical study...
March 2, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28255294/multilevel-pharmacokinetics-driven-modeling-of-metabolomics-data
#18
Emilia Daghir-Wojtkowiak, Paweł Wiczling, Małgorzata Waszczuk-Jankowska, Roman Kaliszan, Michał Jan Markuszewski
INTRODUCTION: Multilevel modeling is a quantitative statistical method to investigate variability and relationships between variables of interest, taking into account population structure and dependencies. It can be used for prediction, data reduction and causal inference from experiments and observational studies allowing for more efficient elucidation of knowledge. OBJECTIVES: In this study we introduced the concept of multilevel pharmacokinetics (PK)-driven modelling for large-sample, unbalanced and unadjusted metabolomics data comprising nucleoside and creatinine concentration measurements in urine of healthy and cancer patients...
2017: Metabolomics: Official Journal of the Metabolomic Society
https://www.readbyqxmd.com/read/28244200/population-pharmacokinetics-of-recombinant-coagulation-factor-viii-singlechain-in-patients-with-severe-hemophilia-a
#19
Y Zhang, J Roberts, M Tortorici, A Veldman, K St Ledger, A Feussner, J Sidhu
BACKGROUND: rVIII-SingleChain is a unique recombinant factor VIII (FVIII) molecule. OBJECTIVES: To (i) characterize the population pharmacokinetics (PK) of rVIII-SingleChain in severe hemophilia A patients, (ii) identify correlates of variability in rVIII-SingleChain PK, and (iii) simulate various dosing scenarios of rVIII-SingleChain. PATIENTS/METHODS: A population PK model was developed based on FVIII activity levels of 130 severe hemophilia A patients (n = 91 for ≥ 12 to 65 years; n = 39 for 1 to < 12 years) who had participated in a single-dose PK investigation with rVIII-SingleChain 50 IU kg(-1) ...
February 28, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28239897/population-pharmacokinetics-of-rituximab-in-patients-with-diffuse-large-b-cell-lymphoma-and-association-with-clinical-outcome
#20
S Rozman, I Grabnar, S Novaković, A Mrhar, B J Novaković
AIMS: Pharmacokinetic (PK) studies suggest that there is a room for improvement in clinical use of rituximab through more individualized treatment. The objective of this study was to characterize rituximab PK in 29 newly diagnosed patients with diffuse large B-cell lymphoma treated with rituximab in combination with cyclophosphamide, doxorubicin, vincristine and methylprednisolone every three weeks. We also evaluated the association of rituximab PK with clinical outcome. METHODS: Rituximab serum levels were determined by enzyme-linked immunosorbent assay and evaluated by a population PK analysis applying non-linear mixed effects modelling...
February 27, 2017: British Journal of Clinical Pharmacology
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